MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR

Model Number SC-2218-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.

Event Description

A report was received that the patient was not getting stimulation due to several contacts out on each lead.Database analysis confirmed the impedance measurements revealed high values on several contacts.The patient will undergo leads replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a replacement procedure and did well postoperatively.Sc-2218-50 sn (b)(4): device evaluation indicated that leads complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that 5 cables were fractured at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.The fractured cables resulted in the reported high impedance complaint.No cables were exposed at the fracture site.Sc-2218-50 sn (b)(4): device evaluation indicated that the lead had no anomalies or deviations were found during the complaint investigation site (cis) review, there was no reason to suspect a manufacturing defect as the source of the reported complaint.

Event Description

A report was received that the patient was not getting stimulation due to several contacts out on each lead.Database analysis confirmed the impedance measurements revealed high values on several contacts.The patient will undergo leads replacement procedure.

• Brand Name: PRECISION SPECTRA®
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 5038773
• MDR Text Key: 24423349
• Report Number: 3006630150-2015-02125
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: SC-2218-50
• Other Device ID Number: M365SC2218500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR